FAS · Electrode, Electrosurgical, Active, Urological
Gastroenterology, Urology · 21 CFR 876.4300 · Class 2
Overview
| Product Code | FAS |
|---|---|
| Device Name | Electrode, Electrosurgical, Active, Urological |
| Regulation | 21 CFR 876.4300 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.
Classification Rationale
Class II (performance standards).
Cleared Devices (58)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251403 | Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) | Dornier Medtech America Inc (Dmta) | Dec 5, 2025 | SESE |
| K250522 | Multi4 System | Multi4 Medical AB | Jun 27, 2025 | SESE |
| K240504 | PLASMA EDGE System | Lamidey Noury Medical | Jun 12, 2024 | SESE |
| K213135 | Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge | Chirurgie Innovation | Mar 2, 2022 | SESE |
| K210651 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | Aug 3, 2021 | SESE |
| K210394 | Electrosurgical accessory | Dornier Medtech America, Inc. | May 19, 2021 | SESE |
| K171965 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | Sep 28, 2017 | SESE |
| K163090 | Plasma Edge System | Chirurgie Innovation | May 23, 2017 | SESE |
| K151976 | Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode | Omnitech Systems, Inc. | Jun 27, 2016 | SESE |
| K152092 | Resection Electrodes | Olympus Winter & Ibe GmbH | Oct 26, 2015 | SESE |
| K120567 | GYRUS AMCI PK BUTTON ELECTRODE | Gyrus Acmi, Inc. | Jun 20, 2012 | SESE |
| K120418 | ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES | Olympus Winter & Ibe GmbH | Jun 20, 2012 | SESE |
| K102781 | RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS | Olympus Winter & Ibe GmbH | Jan 11, 2011 | SESE |
| K100275 | WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS | Olympus Winter & Ibe GmbH | Jul 1, 2010 | SESE |
| K093181 | GYRUS ACMI PK BUTTON ELECTRODE | Gyrus Acmi, Inc. | Feb 24, 2010 | SESE |
| K091511 | MODERN MEDICAL RESECTOSCOPE ELECTRODES | Modern Medical Equipment Mfg., Ltd. | Jan 15, 2010 | SESE |
| K061541 | KSEA BIPOLAR ELECTROTOME | Ksea | Aug 21, 2006 | SESE |
| K053322 | MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS | Roei Medical Technologies, Ltd. | Jan 6, 2006 | SESE |
| K050910 | ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS | Roei Medical Technologies, Ltd. | Jun 16, 2005 | SESE |
| K050454 | OMNITECH FULGURATING ELECTRODE | Omnitech Systems, Inc. | May 27, 2005 | SESE |
| K050488 | TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES | Prosurg, Inc. | Apr 1, 2005 | SESE |
| K031029 | ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM | Arthrocare Corp. | Jun 19, 2003 | SESE |
| K031001 | ACMI VISTA CTR BIPOLAR LOOP ELECTRODE | Acmi Corporation | May 21, 2003 | SESE |
| K022543 | ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM | Arthrocare Corp. | Aug 30, 2002 | SESE |
| K991314 | COAGULOOP | American Medical Systems, Inc. | Jun 29, 1999 | SESE |
| K981256 | ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE | Ximed/Prosure/Injectx | May 12, 1998 | SESE |
| K973820 | USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE | Circon Corp. | May 12, 1998 | SESE |
| K974637 | ELECTRODES/PROBES/DEVICES | Ximed/Prosure/Injectx | Jan 7, 1998 | SESE |
| K974516 | ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE | Endolap, Inc. | Dec 22, 1997 | SESE |
| K974515 | ENDOLAP RESECTOSCOPE ROLLER ELECTRODE | Endolap, Inc. | Dec 22, 1997 | SESE |
| K971512 | AMS COAGULOOP RESECTION ELECTRODE | American Medical Systems, Inc. | Jul 24, 1997 | SESE |
| K970526 | ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP | Arthrocare Corp. | May 28, 1997 | SESE |
| K970717 | VAPOR-TECH SLED ELECTRODE | Northgate Technologies, Inc. | May 8, 1997 | SESE |
| K964365 | RESECTOSCOPE CUTTING LOOP ELECTRODE | Omnitech Systems, Inc. | Apr 22, 1997 | SESE |
| K965093 | OMNITECH RESECTOSCOPE ROLLER ELECTRODE | Omnitech Systems, Inc. | Mar 19, 1997 | SESE |
| K965118 | ENDOCARE MONOPOLAR ELECTRODE | Endocare, Inc. | Feb 25, 1997 | SESE |
| K962653 | MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT | Microgyn Corp. | Feb 4, 1997 | SESE |
| K962538 | BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06) | C.R. Bard, Inc. | Dec 17, 1996 | SESE |
| K961841 | BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06) | C.R. Bard, Inc. | Oct 9, 1996 | SESE |
| K953983 | EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE | Richard Wolf Medical Instruments Corp. | Oct 2, 1996 | SESE |
| K961702 | KSEA VAPORIZATION ELECTRODES | Karl Storz Endoskop GmbH | Aug 29, 1996 | SESE |
| K961069 | ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM | Arthrocare Corp. | May 28, 1996 | SESE |
| K954710 | VAPOR-TECH ROLLER BALL ELECTRODE 24 FR. | Northgate Technologies, Inc. | Apr 24, 1996 | SESE |
| K955531 | ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM | Arthrocare Corp. | Feb 21, 1996 | SESE |
| K953453 | SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES | Symbiosis Corp. | Jan 17, 1996 | SESE |
| K951863 | ROLLER ELECTRODE | Olympus America, Inc. | Aug 24, 1995 | SESE |
| K951897 | POWER RESECTOSCOPE CUTTING LOOP | Power Analytics Corp. | Jul 18, 1995 | SESE |
| K945191 | ENDOSCOPIC ACCESSORY | Un-I-Med, Inc. | May 3, 1995 | SESE |
| K943879 | RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP | American Urologicals, Inc. | Feb 7, 1995 | SESE |
| K944795 | KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES | KARL STORZ Endoscopy-America, Inc. | Dec 21, 1994 | SESE |
| K931763 | HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS | Olympus Corp. | Aug 29, 1994 | SESE |
| K933175 | GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE | Greenwald Surgical Co., Inc. | Apr 1, 1994 | SESE |
| K933174 | GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE | Greenwald Surgical Co., Inc. | Apr 1, 1994 | SESE |
| K933173 | GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE | Greenwald Surgical Co., Inc. | Apr 1, 1994 | SESE |
| K915219 | URETHRAL ELECTRODE SHEATH | Applied Urology, Inc. | Jul 23, 1992 | SESE |
| K905731 | FLEXIBLE ENDOSCOPIC ELECTRODE | Applied Urology, Inc. | Jan 31, 1991 | SESE |
| K903162 | FLEXIBLE ENDOSCOPIC ELECTRODES | North American Sterilization & Packaging Co. | Dec 18, 1990 | SESE |
| K903156 | CONTROL-TIP CYSTOSCOPIC ELECTRODES | North American Sterilization & Packaging Co. | Dec 18, 1990 | SESE |
Top Applicants
- Olympus Winter & Ibe GmbH — 6 clearances
- Arthrocare Corp. — 5 clearances
- Omnitech Systems, Inc. — 4 clearances
- Greenwald Surgical Co., Inc. — 3 clearances
- Ximed/Prosure/Injectx — 2 clearances
